Orange Book product · Brand (NDA)

LILETTA

LEVONORGESTREL

Brand (NDA)NDA 206229RX MEDICINES360

Feb 26, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 26, 2015
11 yr 6 mo ago
Today
Exclusivity ends · I-917
New indication exclusivity (3 years)
Jun 29, 2026
in 10 d
Patent 12004992 expires
Listed drug substance patent expiration.
Oct 06, 2033
in 7 yr 5 mo
Patent 11090186 expires
Listed method-of-use patent (U-2348) expiration.
Oct 24, 2033
in 7 yr 5 mo
Patent 10028858 expires
Listed drug product patent expiration.
Mar 22, 2034
in 7 yr 10 mo
Patent 11571328 expires
Listed drug product patent expiration.
Sep 07, 2040
in 14 yr 5 mo

Active ingredient

LEVONORGESTREL

Strength

52MG

Dosage form

SYSTEM

Route

INTRAUTERINE

TE code

Not listed

Application

NDA 206229

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12004992	Oct 06, 2033	in 7 yr 5 mo	Substance
11090186	Oct 24, 2033	in 7 yr 5 mo	U-2348
10028858	Mar 22, 2034	in 7 yr 10 mo	ProductU-2348
11571328	Sep 07, 2040	in 14 yr 5 mo	Product